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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceCONTAK RENEWAL MODELS H125 AND H120 WITH THE MODEL 2865 VERSION 1.8 APPLICATION SOFTWARE
Generic Namepulse generator, pacemaker, implantable, with cardiac resynchronization (crt-p)
Applicant
GUIDANT CORP.
4100 hamline avenue north
st. paul, MN 55112-5798
PMA NumberP030005
Date Received03/24/2003
Decision Date01/26/2004
Product Code NKE 
Docket Number 04M-0064
Notice Date 02/24/2004
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination Product No
Recalls CDRH Recalls
Approval Order Statement 
APPROVAL FOR THE CONTAK RENEWAL TR. THE DEVICE IS INDICATED S FOLLOWS: THE CONTAK RENEWAL TR PULSE GENERATOR IS INDICATED FOR PATIENTS WHO HAVE MODERATE TO SEVERE HEART FAILURE (NYHA CLASS III/IV) INCLUDING LEFT VENTRICULAR DYSFUNCTION (EF <= 35%) AND QRS DURATION >= 120 MS AND REMAIN SYMPTOMATIC DESPITE STABLE, OPTIMAL HEART FAILURE DRUG THERAPY (AS DEFINED IN THE CLINICAL TRIALS SECTION). THE DEVICE PROVIDES ATRIAL-VENTRICULAR TRACKING MODES TO HELP PRESERVE AV SYNCHRONY, AND ADAPTIVE-RATE PACING FOR PATIENTS WHO WOULD BENEFIT FROM ADJUSTED PACING RATES CONCURRENT WITH PHYSICAL ACTIVITY.
Approval Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
Labeling Part 2
Supplements:  S001 S002 S003 S004 S005 S006 S008 S009 
S010 S011 S012 S013 S014 S015 S016 S018 S019 
S020 S021 S022 S023 S024 S027 S028 S029 S030 
S031 S032 S033 S034 S035 S037 S039 S040 S041 
S042 S043 S044 S046 S047 S048 S049 S050 S051 
S052 S053 S054 S055 S056 S057 S058 S059 S060 
S061 S062 S063 S064 S065 S067 S068 S069 S070 
S071 S072 S073 S074 S075 S076 S077 S078 S079 
S080 S081 S082 S083 S084 S085 S086 S087 S088 
S089 S090 S092 S093 S094 S096 S097 S098 S099 
S100 S101 S102 S103 S104 S105 S106 S107 S108 
S109 S110 S111 S112 S113 S114 S115 S116 S117 
S118 S119 S120 S121 S122 S123 S124 S125 S126 
S128 S129 S130 S131 S132 S133 S134 S135 S136 
S137 S138 S139 S140 S141 S142 S143 S144 S145 
S146 S147 S148 S149 S150 S151 S152 S153 S154 
S155 S156 S157 S158 S159 S160 S161 S162 S163 
S164 S165 S166 S167 S168 S169 S170 S171 S172 
S173 S174 S175 S176 S178 S179 S180 S181 S182 
S183 S184 S185 S186 S187 S188 S189 S190 S191 
S192 S193 S194 S195 S196 S197 S198 S199 S200 
S201 S202 S203 S204 S205 S206 S207 S208 S209 
S210 S211 S213 
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